IceCure
™
Medical Ltd.
DSR3200000 rev. G
ProSense
™
Confidential
User Manual
8
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1
OVERVIEW
1.1
Introduction
ProSense™
cryoablation system is a comprehensive system for cryotherapy of human
tissue based on IceCure
Medical’s technology. All established cryotherapy techniques
utilize a low temperature cryogen under pressure. The ProSense™
cryoablation system
utilizes liquid nitrogen that causes the cryoprobe to reach very low temperatures thereby
freezing tissue with which it comes in contact.
1.2
Intended use
The IceCure Family device, including the ProSense cryoablation system is intended for
cryogenic destruction of tissue during surgical procedures by the application of extreme
cold temperatures. The IceCure Family device, including the ProSense cryoablation
system is indicated for use as a cryosurgical tool in the fields of general surgery ,
dermatology, neurology (including cryoanalgesia), thoracic surgery , ENT, gynecology,
oncology , proctology, and urology . The system is designed to destroy tissue by the
application of extreme cold temperatures including prostate and kidney tissue, liver
metastases, tumors, skin lesions, and warts. The IceCure Family device, including the
ProSense cryoablation system may be used with an ultrasound device to provide real-
time visualization of the cryosurgical procedure.
The system is suitable for use in a number of cryotherapy applications. However, it is
ONLY indicated for use in patients whom the practitioner has deemed eligible for
cryotherapy.
The IceCure Family cryoablation system is intended for cryogenic destruction of tissue
during surgical procedures by the application of extreme cold temperatures. The IceCure
Family device, including the ProSense cryoablation system is indicated for use as a
cryosurgical tool in the fields of general surgery, dermatology, neurology (including
cryoanalgesia), thoracic surgery , ENT, gynecology, oncology , proctology and urology as
detailed below. The system is designed to destroy tissue by the application of extreme
cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin
lesions, and warts.
